In a decision hailed as “great news” and “long overdue,” the regulator Health Canada announced Thursday that it has approved use of the medical abortion pill known as RU-486, sold under the brand name Mifegymiso.
“The decision to authorize Mifegymiso for the Canadian market was made further to a thorough review of the data package provided by the sponsor that supported the safety, efficacy and quality of the product,” said the agency.
An application of approval for the pill, which is also known as mifepristone, has been before the regulatory agency since December 2012. While its use will now be permitted, it can only be obtained through a physician’s prescription and is allowed up to seven weeks after fertilization.
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Regulators made the decision on Monday and on Wednesday notified drug manufacturer Linepharma, which will soon begin producing the pill.
“The approval of mifepristone is great news for women in Canada,” said Vicki Saporta, president and CEO of the National Abortion Federation (NAF) and NAF Canada, in a press statement, adding that the pill “has been safely and effectively used by millions of women worldwide to terminate an early pregnancy since 1988, and is available in 60 other countries. It’s long overdue that Canadian women also have access to the gold standard for medical abortion care.”
According to NAF, the pill will become available in Canada in 2016.
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